Evaluating the safety of dapagliflozin in patients with type 2 diabetes

This study looked at the side effects of dapagliflozin (Farxiga) for patients with type 2 diabetes (T2D). It found that dapagliflozin was well tolerated and led to less kidney injury for patients with T2D.

T2D is a disorder that causes high levels of glucose (sugar) in the blood. Over time, high blood glucose can cause a number of complications including damage to the kidneys.

The kidneys contain small filters that remove waste from the blood. The sodium-glucose transporter 2 (SGLT2) is a protein in these filters. SGLT2 proteins reclaim glucose from the urine back into the blood. Dapagliflozin is a medication that blocks SGLT2. By causing more glucose to leave the body in urine, dapagliflozin lowers blood glucose. Dapagliflozin also prevents high levels of glucose from damaging the kidney’s delicate filters.

Other SGLT2 inhibitors have serious side effects including kidney injury, infections, and ketoacidosis (a complication of diabetes where fat is broken down too quickly). It is unclear whether dapagliflozin has these side effects.

This study used data from 17,143 patients with T2D who were at risk for heart disease. Half of the patients were assigned to dapagliflozin, and half took a placebo (inactive pills). The patients were followed for an average of 4.2 years.

Acute (short-term) kidney injury was significantly less common for patients taking dapagliflozin (0.8% vs. 1.2%). Fewer patients taking dapagliflozin had an episode of hypoglycemia (very low blood glucose). This was true both for patients taking insulin (1.3% vs. 1.7%) and those not taking insulin (0.2% vs. 0.4%). There was no difference in cancer occurrence or bone fractures between groups.

Ketoacidosis was rare, but it was more common for patients taking dapagliflozin (27 vs. 12 patients). Genital infections were also more common in patients taking dapagliflozin (74 vs. 7 patients).

This study found that dapagliflozin is a safe medication and does not cause kidney injury for use in patients with T2D.

AstraZeneca, the owner of the Farxiga patent, funded this study and is the employer of four of the authors.